These COVID-19 tests are being recalled after the FDA warns of ‘significant concerns’ about bacterial contamination

The U.S. Food and Drug Administration (FDA) has issued an alert warning people not to use select COVID-19 at-home tests due to “significant concerns” over bacterial contamination that may both affect the tests’ results and “pose safety concerns” to the user. Here’s what you need to know:



What’s happened? Select COVID-19 at-home tests made by SD Biosensor, Inc. and distributed by Roche Diagnostics have been found to have bacterial contamination of organisms including Enterococcus, Enterobacter, Klebsiella, and Serratia. These bacteria can cause illness in people with weak immune systems. They can also affect the reliability of the COVID-19 test, giving false negative or false positive results. SD Biosensor, Inc. has initiated a recall of the tests. What tests are contaminated? The contaminated tests were sold under the name  “Pilot COVID-19 At-Home Test.” The FDA has an image of the test’s packaging on its website here . Where were the contaminated tests sold? The tests were distributed to CVS Health stores and Amazon. The FDA is currently working to find out how many of the tests were then sold on to consumers. At this time, the FDA believes at least 516,000 contaminated tests were distributed. How do I know if my test is contaminated? All boxes of the Pilot COVID-19 At-Home Test kits will have a lot number on them. The FDA has a list of the lot numbers that are covered under the recalls. You can check that list here . If the lot number from the box matches a number on the list, then you have a test kit that is involved in the recall. What do I do if I have a contaminated test kit? Do not handle the contents of the kit, including the plastic test tube that contains the liquid solution. The FDA says to throw out the entire test kit in your household trash, and do not pour the liquid down a drain. If the liquid gets on your skin or in your eyes, the FDA says to flush them with large amounts of water. If I’ve used a contaminated test, what should I be on the lookout for? The FDA says signs of bacterial infection from the tests include fever, red eyes, and discharge. If you develop these or other symptoms, the FDA advises you to seek medical attention. Has anyone been harmed by the contaminated tests? As of the time of this writing, the FDA says it has yet to receive any reports of injuries, adverse health consequences, or death associated with the contaminated test kits.